Standard Swedish standard · SS-EN ISO 14971:2007

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Status: Withdrawn

· Replaced by: SS-EN ISO 14971:2009
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Standard Swedish standard · SS-EN ISO 14971:2007

Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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Scope
This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

Subjects

General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10)


Buy this standard

Standard Swedish standard · SS-EN ISO 14971:2007

Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Subscribe on standards - Read more Dölj
Price: 1 731 SEK
standard ikon pdf

PDF

Price: 1 731 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-60387

Edition: 2

Approved: 4/2/2007

No of pages: 88

Replaces: SS-EN ISO 14971/AC:2002 , SS-EN ISO 14971 , SS-EN ISO 14971/A1 , SS-EN ISO 14971

Replaced by: SS-EN ISO 14971:2009